Ethicon received seven complaints for one lot of undyed PDS™ II sutures regarding low tensile strength. Internal testing on returned product from this lot confirmed that some PDS™ II sutures from this lot did not meet Ethicon's tensile strength requirement. An investigation identified additional lots across the PDS™ Plus Antibacterial and PDS™ II suture families that have the potential to be affected by the same root cause as the lot that received the complaints. Recall Start Date: August 8, 2023
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